Solid pharmaceutical compositions such as tablets and capsules are often contained for dispensing in blister packages. Generally a blister package comprises a moulded plastic sheet having one or more depressions each defining a blister chamber, typically for containing a tablet or capsule; these depressions are commonly referred to as ‘blisters’. This sheet is generally covered by a thin layer of foil for sealing the tablets or capsules within the blisters. Pressing on a blister causes the tablet or capsule contained in that blister to penetrate the foil layer so that it can easily be removed from the package. The blister from which the tablet is removed is left deformed, and the foil is torn in the region below the blister, but the other blisters remain intact. Blister packages are usually further packed in a paper box together with a leaflet containing information about the medication. This secondary package has the function of holding items securely, avoiding tablets loss due to undesired rupture during transportation.
Blister packages are generally transported by air, sea or rail and travel by road for at least part of their journey from the manufacturer to the pharmacy and from the pharmacy to the end user. Further package handling involves dissembling into smaller units of big pallet loads for stacking on shelves in distribution warehouses and then picking off the shelves to assemble mixed product loads to meet the user needs. This means that packages and their content are subjected to vibrations and shocks, temperature fluctuations, mechanical pressure, humidity changes and variation in atmospheric pressure. These fluctuations can lead to seal failure, cracking of blisters, scuffing of labels and decorated surfaces. Packages may also experience reduced atmospheric pressure and temperature fluctuation during distribution, which may lead to deterioration of the properties of the material of the package leading to undesired ruptures.
Despite these fluctuations, the packages still need to meet several criteria like: i) if sterility is needed, it must be maintained for the duration of the specified shelf life; ii) normal distribution hazards must be tolerated without product or package damage; iii) the pharmaceutical composition must tolerate physical contact with the package without adverse reactions; iv) packages must tolerate the climatic conditions; v) the package surface must be of suitable material to accept labelling and/or printing and have sufficient area therefore; vi) comply with national regulations.
In order to protect a blister package and its content during transportation, several approaches have been used.
One known approach provides a solution to the aforementioned problem by using external “boxes” to contain the blister packages, e.g. typically used with blister packages containing oral contraceptives.
For example, WO 07072494 describes a multi-layer thermoformed, translucent pharmaceutical packaging blister container consisting of poly vinyl chloride (PVC), which can be metalized so as to achieve a degree of opacity.
US 2003/098257 describes a credit card-sized carrier for a medication. The carrier is composed of a lower housing having a cavity which houses a medicament wafer. A cover is removably attached to the lower housing to enclose the cavity.
WO 08104765 relates to a container suitable for use in packaging pharmaceutical products such as tablets and capsules. The container can be withdrawn from a box or sleeve to a fully extended position whereby a user can remove any item stored in the container.
In some other approaches an external carrier is used, where by external carrier is meant an external packaging, mainly hard paper or cardboard, which can house a variety of blister packages.
For example, US 2007/0187273 discloses a packaging container for displaying and housing products. The packaging container may include tear-resistant housing that encloses an opaque tray made from a paper material. An insert card may be used within the housing to reinforce the container so as to obtain a clamshell package.
US 2005/0077203 relates to a press through blister package (PTP) case with one or more pills therein. The PTP case includes foldable members to accommodate the blisters.
US 2006/289328 describes a foldable package including a blank having a face panel and a back panel, where a blister pack is sealed between them. In this way the blisters are aligned over gates and protrude through apertures and tabs and form a composite pull tab. To remove an item from a blister, the pull tab is pressed out of the panels, the tab strip is peeled from the back panel, and pressure is applied to force the item through the backing sheet of the blister pack and the exposed gate.
WO08014862A relates to a packaging for solid pharmaceutical forms which is further packed into a secondary container to improve its protection.
In same other approaches, solid dispensers for containing and dispensing pills have been used.
For example, U.S. Pat. No. 5,788,079 describes a pill sorting container which is characterized by three layers: i) a recessed support made of rigid plastic material with cavities therein, ii) a container defining sheet made of plastic, designed to fit into the support for containing the pills, and iii) a container sealing sheet made of self-adhesive paper.
U.S. Pat. No. 5,381,904 discloses a dispenser for medical preparations including a rectangular box which accommodates an insert for containing a series of compartments for receiving the medical preparations. The dispenser is opened by shutters which can slide.
US 2005/0084700 describes a pharmaceutical compositions container characterized by a solid carrier, which can be made of plastic, having cavities where cup-shaped inserts can be formed with a mould material. These inserts may be designed freely so as to fit the pharmaceutical compositions, e.g. tablets, to be contained.
An alternative solution to the problem is described by US 2003/102247 where blister packages are wound around each other into a container.
The above discussed holders, dispensers and pharmaceutical packages are deficient in several aspects. Significantly, none of the above references presents a convenient, simple and effective way of protecting a blister packaging for medical use and its content from undesired rupture during transportation and handling; e.g. boxes protecting medical packaging can generally not withstand pressure strain from mail delivery. The ability to withstand pressure strain from mail delivery is a requirement that has been arising in particular in recent times, because of the development of online pharmacy systems, where patients can order medicine on line and get them delivered to their addresses.
Further, none of the above references specifically addresses a way to facilitate the opening of a blister package where these conditions of safety are present. Such opening can be particularly difficult for elderly or weak people. Therefore, there remains a need for a simple, inexpensive and convenient means for providing a disposable container for pharmaceutical compositions which is easy to open and has a high degree of safety against undesired rupture and pressure. Automatic handling of medical packages may involve robotic intervention. Robotic handling may comprise systems which pick and transport medical packages by applying suckers to different surfaces of the package by means of vacuum. Generally, as medical packages have a high degree of flexibility, the packages may be deformed upon automatic handling. For example, upon application of suckers on the top surface of the package, this surface may bend inwards causing poor handling and failure in grasping of the medical package.
Hence, an improved medical package that can be robotically handled without risk of permanent damage would be advantageous.
Hence, an improved container for pharmaceutical compositions would be advantageous, and in particular an improved disposable container for pharmaceutical compositions which could be able to protect the contained pharmaceutical compositions during transportation in hard conditions, e.g. sent by normal mail, would be advantageous.